09STATE108138

VZCZCXR03865
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DE RUEHC #8138 2921950
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O 191930Z OCT 09
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TO ALL DIPLOMATIC AND CONSULAR POSTS COLLECTIVE IMMEDIATE
RUEHTRO/AMEMBASSY TRIPOLI IMMEDIATE 0353
RUEHRY/AMEMBASSY CONAKRY IMMEDIATE 2014

UNCLAS STATE 108138

SIPDIS

E.O. 12958: N/A
TAGS: EAGR ETRD ECON

SUBJECT: FDA REPORTABLE FOOD REGISTRY
SUBJECT:

1.1 . This is an action request. Please see para 8.

1.2 . On September 8, 2009, the U.S. Food and Drug
Administration launched the Reportable Food Registry
(RFR or the Registry), an electronic portal for industry
to report when there is reasonable probability that an
article of food will cause serious adverse health
consequences to humans or animals. The Registry helps
the FDA better protect public health by tracking
patterns of adulteration and targeting inspections . The
Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-085), section 1005 directs the FDA to
establish a Reportable Food Registry for Industry. The
RFR applies to all FDA-regulated categories of food and
feed, except dietary supplements and infant formula.

1.3. Food Facilities that manufacture, process, pack, or
hold food for human or animal consumption in the United
States (Responsible Parties) should be registered under
section 415(a) of the FD&C Act (21 U.S.C. 350d), Such
facilities are required to report via the RFR portal
(http://rfr.fda.gov) within 24 hours if they find a
reasonable probability that the use of, or exposure to,

an article of food will cause serious adverse health
consequences or death to humans or animals. Federal,
state, and local government officials may voluntarily
use the RFR portal to report information that may come
to them about reportable foods .

14. The reporting requirement applies to all foods and
animal feed regulated by the FDA, except infant formula
and dietary supplements, which are covered by other
regulatory requirements. Some examples of reasons a food
may be reportable include bacterial contamination,
allergen mislabeling or elevated levels of certain
chemical components. More information is available at

www. fda. gov/ReportableFoodRegistry .

15. The opening of the RFR electronic portal reflects a
fundamental principle of the President's Food Safety
Working Group that "preventing harm to consumers is our
first priority." "President Obama has pledged to
strengthen food safety, " said Commissioner of Food and
Drugs Margaret A. Hamburg, M.D. "The opening of the
Reportable Food Registry electronic portal represents a
significant step toward that pledge." "By fostering
real-time submission to the FDA of information on food
safety hazards, the registry enhances FDA's ability to

act quickly to prevent foodborne illness," said Michael
1R. Taylor, senior advisor to the Commissioner. "Working
with the food industry, we can swiftly remove
contaminated products from commerce and keep them out of
consumers ' hands . "

1.6. A Responsible Party must 1) Investigate the cause

if the adulteration of food may have originated with the
responsible party, 2) submit initial information,

followed by supplemental reports, and 3) work with FDA
to follow up as needed. A Responsible Party is not
required to report if the adulteration originated with
the responsible party and it found the problem before
the food was shipped and corrected the problem or
destroyed the food.

f.7 . In emergencies, consumers, food retailers and food

service operators should continue to call FDA at 301-
443-1240. For less urgent problems, contact the FDA
consumer complaint coordinator in your geographic area
or see Your Guide to Reporting Problems to FDA. For
more information see The RFR Guidance at
www. fda. gov/ReportableFoodRegistry
Consumer Inquiries: 888-INFO-FDA.

1[8 . ACTION REQUEST: Posts draw from the information in

points 2 through 7 to discuss this issue with the
appropriate Ministries. Where FAS or HHS officials are
present, Econ officers should coordinate delivery of the
talking points. Please report substantive comments only
via cable, at or below the SBU level. If you have
questions regarding this program, please contact
Vashti. Klein (vashti.klein@fda.hhs.gov) or Ann Ryan
( ryanarn® state . gov ) .

CLINTON